The invention relates to a method for training staff for quality control when filling amorphous products into primary packaging means. Furthermore, the invention relates to a test set for training staff for quality control when filling amorphous products into primary packaging means, and to a kit which comprises the test set and a UV light source. Furthermore, the invention relates to a use of a test set and a method for producing a test set. Devices and methods in accordance with this disclosure can be used, in particular, in the pharmaceutical industry to train staff used in quality control when filling amorphous products. The amorphous products can, in particular, be pharmaceutical products, for example diagnostic products and/or therapeutic products. In particular, this can relate to amorphous products in the form of fluid media, in particular in the form of liquids. In addition to use in the pharmaceutical industry, applications of this disclosure are also possible in medicine, in the natural sciences, in engineering or in other fields, for example within the scope of packaging foodstuffs.
The prior art has disclosed a multiplicity of methods and devices, by means of which amorphous products, in particular homogeneous amorphous products such as, e.g., liquids, can be packaged in appropriate primary packaging means, in particular in vessels. Particularly in the field of pharmaceutical products and the filling thereof into appropriate primary packaging means, such as syringe bodies, glasses, phials or similar vessels, quality control plays a significant role. Thus, automated or manual quality controls have to be carried out in many cases before, during or after filling of the amorphous products into the primary packaging means, within the scope of which quality controls the primary packaging means with the products contained therein are examined for contaminants and/or damage.
In the following text, reference is made in particular and without restricting further fields of use to the packaging of pharmaceutical products in particular, i.e., therapeutic and/or diagnostic products and, in particular, medicaments. In particular, this can relate to liquid medicaments. In particular, the medicaments can be parenteral medicaments or so-called parenterals, i.e., medicaments which are administered by means of an injection. In the case of such parenterals, there generally is a requirement for quality control in which 100% of the filled primary packaging means are controlled, i.e., in which no filled primary packaging means are brought into circulation without quality control.
In general, the quality control can take place in an automated manner in particular. By way of example, the automated quality control can comprise an automated optical quality control, for example by means of appropriate camera systems and optionally by means of appropriate image evaluation systems. Such automated quality controls can be used, in particular, in the field of a line production.
However, as an alternative or in addition to an automated quality control, there is also quality control by appropriately trained staff in many sectors having the filling of primary packaging means with parenterals. In the following text, such non-automated quality control by trained staff is also referred to as “manual quality control” or “human quality control”. Such a human quality control can take place, in particular, in the case of batch productions with a low volume.
However, before employment in manual quality control, the staff employed for this must be appropriately trained. Thus, in the case of manual optical control of parenterals, the staff used for this activity are generally trained with the aid of prepared test sets. As a result of this training, the staff must be able to reliably identify contaminants and damage. The test sets used for this purpose for example contain a plurality of primary packaging means (primary packages) such as pre-filled syringes and/or phials (vials), which are filled with the amorphous product or a model product (no distinction is made in the following in relation to the test set), for example a model solution. Additionally, at least one fault is provided in each case in some or a number of the primary packaging means of the test set, which fault must be identified by the staff. In particular, this fault can be a contaminant and/or a different type of fault, for example damage and/or a faulty packaging such as, e.g., a faulty closure of the primary packaging means. By way of example, different particles with various sizes, such as, e.g., metal chips, plastic splinters, glass splinters, fibers or hairs, are introduced into the test sets. These contaminants and/or this damage must be dependably and reliably identified by the staff to be trained. By way of example, a test set can be configured in such a way that 20 to 30% of the filled primary packaging means of this test set have appropriate faults.
However, when assessing a training result, there can, in practice, repeatedly be an incorrect assessment. Thus, in particular, the case may occur where particles are not identified because they cannot be identified by the staff to be trained. By way of example, particles may be hidden in the meniscus of a surface of the amorphous medium or in frothing. Furthermore, particles may be hidden in recesses in the primary packaging means, for example between a plug and a glass wall and/or in a needle. Such cases of non-identification of the particles should, in principle, be separated out when evaluating the training success from a non-identification due to lack of attentiveness by the staff to be trained; however, this is not possible in practice in conventional training methods. As a result of this lack of ability to distinguish between inadequate training results which can be traced back to the lack of attentiveness and inadequate training results which can be traced back to an, in principle, impossibility of identification of the contaminant, an evaluation of the training success is hardly possible in many cases, and the corresponding circumstances can only be elusive.